Azacitidine product-specific bioequivalence guidance

This document provides product-specific guidance on the demonstration of the bioequivalence of aprepitant.

Keywords: Bioequivalence, generics, aprepitant

Abbreviations:

• BCS Classification: Biopharmaceutics Classification System
• AUC_0-t: area under the plasma concentration curve from administration to last observed concentration at time t
• AUC_0-72: area under the plasma concentration curve from administration to last observed concentration at 72 hours
• C_max: maximum plasma concentration

Current version - effective 1 December 2025

Azacitidine powder for suspension for injection 25 mg/ml product-specific bioequivalence guidance

Adopted Reference Number: EMA/CHMP/172895/2023 Legal effective date: 01/12/2025

First version

Overview of comments received on ‘Draft azacitidine powder for suspension for injection 25 mg/ml product-specific bioequivalence guidance’

Reference Number: EMA/188720/2025

Draft azacitidine powder for suspension for injection 25 mg/ml product-specific bioequivalence guidance

Draft: consultation closed Consultation dates: 15/01/2024 to 30/04/2024 Reference Number: EMA/CHMP/172895/2023